Company Welcome to our Blog
If you are seeking regulatory advice, ideas to develop into new markets or product assessment, these topics are covered in our blog posts. Click the links for the latest news and events
In 2018 EFSA addressed the risk assessment gap with a methodology to calculate the re-entry interval (REI) for workers. Within the European Food Risk Assessment Fellowship Programme (EU-FORA) assignment, a methodology was developed to calculate agricultural-use-specific and pesticide-specific REIs for which period workers should wear gloves.
In November 2018 IUCLID 6.3 has been published which introduces a new web-based user interface and includes latest OECD Harmonised Templates and the European Poison Centres notifications.
EFSA technical report reflects the outcome on issues during peer review of active substances under Regulation (EC) No 1107/2009. The main issues identified related to genotoxicity of products and principles of (Q)SAR and read-across.
The objective is to improve the collection, management and sharing of data and assist the development of a holistic approach to assessing bee health in Europe.
The partnership involves active industry members from the crop protection and veterinary medicines industry and has a focus is on:
Chemicals and REACH
In May 2018 the cloud version of the chemical data management tool IUCLID is now available to companies of all sizes. ECHA has changed the terms of the service to support future registration activities, as companies will continue to submit updates of existing registrations and new dossiers.
The IUCLID Cloud benefits those that:
The public consultation on the draft Guidance document ended on 31 January 2018 with over 2000 comments received. The draft guidance document is now subject to revision then subject to consultation by ECHA, EFSA and the European Commission with the final guidance document to be published in June 2018.
EFSA develop the opinion of risk for amphibians and reptiles for crop protection products. EFSA propose specific protection goals to protect important ecosystem and highlight uncertainties, knowledge gaps and research needed.
EFSA’s updated risk assessments on the potential risks to bees from neonicotinoid pesticides will be finalised in February 2018. The assessments for clothianidin, imidacloprid and thiamethoxam will be finalised following a final round of consultation with pesticide experts in the Member States.
At the Standing Committee Pesticides legislation meeting on December 13 2017, Member States representatives voted in favour of a new draft Regulation for setting criteria for the identification of Endocrine Disruptors (ED) used in pesticides. The draft Regulation goes for scrutiny by the Council and the European Parliament, who have three months to examine it before final adoption by the Commission.
REACH IT updated and record number of registrations submitted for the last deadline
The statistics about the registrations for the May 2018 deadline were updated with 12 131 registrations have been submitted for 5 596 substances. The biggest number of registrations were recorded from Germany, the United Kingdom and France. ECHA have also updated the list of substances for which a lead registrant has been declared in REACH-IT. The list now includes 12 354 substances that have a joint submission and are either already registered or going to be registered by the REACH 2018 deadline.
Registrations have been submitted since 2008 via more than 62 000 dossiers. The most frequently registered chemical is ethanol with 500 registrations. Germany is in first place in terms of which country has received registrations with 13,387 registrations for over 5,800 substances.
The Swedish Chemicals Agency plans to restrict the private use of chemical plant protection products so only products containing low-risk active substances according to Regulation 1107 may be authorised for private use. The new regulations could enter into force by start of 2019.
Substances no longer supported in the review programme must be phased out by 4 November 2017.If a substance is on the list for your product-type, your product can stay on the EU market while you wait for the substance to be approved. If a substance is no longer included in the review programme for your specific use, the substance will no longer be made available on the EU market after November 04, 2017 and no longer used after May 04, 2018.
Can exposure to agrochemicals cause ill health in humans? Scientists currently rely on experimental toxicology evidence, such as animal or cell studies, to assess their safety. A new approach proposed by EFSA could help improve understanding by making better use of epidemiological studies on human health.
EFSA’s Panel on Plant Protection Products and their Residues has tested a method that could enable risk assessors to establish a biological cause and effect link between exposure to compounds used for crop protection and ill health. The method is designed to make better use of data from epidemiological studies within the conceptual framework known as the Adverse Outcome Pathway (AOP) used by OECD members as a tool for risk assessment.
February 2017 Top Stories
Technical advice on how to perform hazard and exposure assessment and risk characterisation for biocidal active substances and products with respect to efficacy.
November 2016 Top Stories
New PPPAMS website address from June 2016, applications for emergency authorisation of products have been managed through PPPAMS.
On 30th September, the Commission launched the Endocrine Active Substances Information System (EASIS).
ECHA will stop publishing the list of pending applications for the Article 95 list of active substance and product suppliers in November 2016. November 2016 is over 1 year after the deadline and ECHA considers the official Article 95 list to now be a sufficient source of information.
Information on the identity, hazards, uses and risks of substances compiled in previous phases must be documented in a standardised IT format in registration dossiers.
Companies that have received an authorisation can apply more than once by submitting a review report to ECHA. In other words, authorisation decisions can be extended after the review period has come to an end. ECHA has just published a note on how review reports would be submitted and reviewed. The first review reports on the use of DEHP are expected in mid-2017.
Stay connected with us!
To learn more about LKC, please visit us:
EU Regulatory Forum: Crop Protection, Biocides and REACH